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ABOUT THE COMPASS STUDY

The second trial (COMPASS) compared the pharmacokinetics of twice daily, immediate release Lamictal to once daily Lamictal XR in patients thirteen years of age and older with epilepsy. The open label, conversion study consisted of a 2 week base line phase with Lamictal immediate release, a 2 week treatment phase with Lamictal XR and a 1 week treatment phase with Lamictal immediate release. The study outcomes included lamotrigine pharmacokinetics upon conversion and seizure frequency during each treatment phase.

Results showed the steady state trough concentrations for Lamictal XR were equivalent to or higher than those of Lamictal immediate release depending on concomitant AED. In addition, there was no change in the median weekly seizure frequency among the groups.

ABOUT EPILEPSY

Epilepsy, defined by recurrent unprovoked seizures, is a change in sensation, awareness, or behavior brought about by an electrical disturbance in the brain. The kind of seizure a person has depends on which part and how much of the brain is affected by the electrical disturbance that produces seizures. Generalized seizures are seizures that involve the entire brain from the outset. Partial seizures, which are more common, involve a restricted area of the brain. In approximately 70 percent of cases, the cause of epilepsy is unknown. According to the Epilepsy Foundation, more than three million Americans of all ages are living with epilepsy.

ABOUT LAMICTAL IMMEDIATE RELEASE (IR) FORMULATION

Lamictal is indicated 1) as adjunctive therapy for partial seizures, primary generalized tonic-clonic seizures, and the generalized seizures of Lennox-Gastaut syndrome in adults and pediatric patients as young as 2 years and 2) for conversion to monotherapy in adults with partial seizures taking carbamazepine, p
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